Aseptic fluid sampler and method

ABSTRACT

A method of using an aseptic sampling arrangement. The sampling arrangement includes a septum cartridge and a securing element for use with a fluid enclosure. A locking arrangement is provided to allow selective access to the septum cartridge and the securing element. The sampling arrangement further includes a needle, a tube, and a collection bag. The sampling arrangement can be used to monitor the quality of a fluid product. The method of monitoring includes obtaining a fluid product sample from the fluid enclosure within the collection bag. The collection bag is then incubated for a period of time during which oxygen permeates the bag to simulate post-pasteurizing conditions and/or pre-pasteurizing conditions of the fluid product. The method further includes monitoring the level of contamination detected within the fluid product sample.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 10/875,842,filed Jun. 24, 2004; which is a continuation-in-part of application Ser.No. 10/022,294, filed Dec. 14, 2001, which applications are incorporatedherein by reference.

FIELD OF THE INVENTION

This disclosure concerns a sampling arrangement. More specifically, thisdisclosure describes the assembly and method of use of a samplingarrangement for aseptic, continuous sampling of a fluid material.

BACKGROUND OF THE INVENTION

There are numerous applications wherein it is desirable to obtaindiscrete or continuous samples from fluid transportation systems orfluid processing enclosures. Enclosures and fluid transportationsystems, as used herein, refer to any closed containment structurewithout respect to its size. Thus it includes such small enclosures suchas cans that may be used in shipping starter bacteria from a culturelab. On the other end of the spectrum, it includes large tanks andassociated pipelines, which may have capacities of several thousandgallons, such as are used in the dairy processing industry.

Efficient and effective techniques and apparatus for obtaining asepticsamples from such systems and enclosures, are particularly desirable.Examples of industries that require such aseptic sampling include, butare not limited to, the pharmaceutical, bioengineering/biotechnology,brewing/distilling, food processing and dairy processing industries.Applications for such samplings range broadly from process monitoring tolaboratory and research applications. For example, sampling is commonlyused on dairy farms for herd management or in regulated manufacturingfacilities. The sampling is used to detect and control microbialcontamination, spoilage microorganisms, food-borne illness, andenvironmental mastitis both within systems being sampled and externallyof such systems. While preferred embodiments of this invention will bedescribed with respect to its sampling use and application in the dairyindustry, it will be understood that the invention is not to beconstrued as limited to use in that industry or to the applicationdescribed, or to any limitations associated with the specifics of thecomponents or methods disclosed with respect to such preferredembodiments.

Various methods and devices have been employed to perform samplingtasks. Typical sampling techniques commonly involve discrete or isolatedsampling from a laminar portion of a fluid transport line. Typical suchsampling systems and techniques that have been used in the dairyprocessing industry are described in U.S. Pat. Nos. 4,941,517;5,086,813; and 5,269,350. To the extent that such patents may be used toassist the reader in understanding principles and examples of samplingapparatus and methods, they are herein incorporated by reference.

While the apparatus and techniques described in these patents areparticularly applicable to systems designed to accommodate them, therealso exists a need to perform sampling in existing enclosures and fluidtransportation systems that have not been designed for samplingfunctions. Such systems typically require redesign or retrofitting toaccommodate sampling functions. Such retrofitting can be expensiveand/or difficult to achieve, can require significant system downtime inimplementation of the sampling function and/or replacement of parts tomaintain the system, or can lead to system degradation or contaminationof the system being sampled. For example, one known method of discretesampling of fluid involves inserting a needle through a sealing gasketlocated between connecting ends of pipelines of the fluid transportationsystem. Problems arises from this method as this method is not asepticbecause the gasket becomes so perforated after repeated sampling thatthe gasket may lose its sealing integrity or introduce contaminants intothe system through the perforations. This method requires that thegasket be replaced, which can become expensive both in labor costs andshut down costs.

There are many applications wherein it is desirable to obtain acontinuous sample from fluid transportation systems or fluid processingenclosures. The discrete sampling methods typically extract a discretesample size limited to the volume of a hypodermic needle and syringe.Typically the needle is inserted, fluid is drawn, and the needle isremoved. It would be beneficial in some applications to have a systemthat could draw a continuous, controlled and constant sample volume overan extended period of time. A sampling device that facilitates thisfeature would also need to accommodate larger volume samples and a meansto cool the sample during longer sampling time periods. While continuoussampling techniques have been tried, they have generally not beenparticularly effective, efficient or reliable in maintaining the asepticcondition of the system during the sampling interval.

Known discrete sampling techniques have not proven to be readilyadaptable to continuous sampling techniques. For example, if the sampleis taken from a region of laminar fluid flow, the sampling needle cancreate a venturi effect in the fluid flow being sampled, which can causereverse flow siphoning from the collected sample and back into thesampled fluid. If such suction effect is disrupted by providing thesampling system with an air gap, the aseptic nature of the samplingsystem is compromised.

Improvement in methods and devices for sampling is needed, generally tobetter accommodate: ease of repeated continuous sampling of largevolumes; structural integrity of fluid transport equipment; managementof contamination; and convenience of continuous and controlled volumesampling. The present invention addresses these and other needs forcontinuous sampling of fluid transportation systems or fluid processingenclosures.

SUMMARY OF THE INVENTION

One aspect of the present disclosure relates to a method of monitoringquality of a fluid product. The method includes providing an asepticsampling arrangement including a septum and a collection bag. A sampleof the fluid product is obtained by aseptically collecting the fluidproduct in the collection bag. The collection bag is incubated for aperiod of time. The method also includes monitoring the level ofcontamination within the sample of fluid product during the period oftime.

Another aspect of the present disclosure relates to a samplingarrangement for use with a fluid enclosure. The sampling arrangementincludes a septum configured for receipt within an aperture of the fluidenclosure. The septum is constructed for penetration of a needletherethrough to provide fluid communication between an internal volumeof the fluid enclosure and a collection bag. The sampling arrangementalso includes a locking arrangement configured to provide selectiveaccess to the septum.

Yet another aspect of the present disclosure relates to a samplingarrangement having a septum, a securing element, and a lockingarrangement. The septum is configured for receipt within an aperture ofa fluid enclosure. The securing element configured to secure the septumwithin the aperture of the fluid enclosure. The locking arrangementincludes a base, a cover, and a locking device, and is configured toprovide selective access to the septum and the securing element.

Still another aspect of the present disclosure relates to a fluid systemincluding a fluid enclosure, an aseptic sampling arrangement, and alocking arrangement. The aseptic sampling arrangement has a septum and asecuring element, the septum being secured within an aperture of thefluid enclosure by the securing element. The locking arrangementprovides selective access to the sampling arrangement.

And another aspect of the present disclosure relates to a method ofproviding access to a fluid enclosure. The method includes positioning aseptum of an aseptic sampling arrangement within an aperture of thefluid enclosure and securing the septum within the aperture of the fluidenclosure with a securing element. The method further includes enclosingthe septum and the securing element within a locking arrangement toprevent unwanted access to the septum and the securing element andlocking the locking arrangement to permit only selective access to theseptum and the securing element.

A variety of examples of desirable product features or methods are setforth in part in the description that follows, and in part will beapparent from the description, or may be learned by practicing variousaspects of the disclosure. The aspects of the disclosure may relate toindividual features as well as combinations of features. It is to beunderstood that both the foregoing general description and the followingdetailed description are explanatory only, and are not restrictive ofthe claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring to the drawings wherein like numerals represent like partsthroughout the several views,

FIG. 1 is a schematic illustration of a system incorporating acontinuous sampling arrangement in accordance with the principlesdisclosed;

FIG. 2 is a detailed schematic illustration of one embodiment of thecontinuous sampling arrangement in accordance with the principlesdisclosed;

FIG. 3 is a side view of a pipe elbow depicted in the samplingarrangement of FIG. 2;

FIG. 4 is a top view of the pipe elbow depicted in FIG. 3;

FIG. 5 is a top view of one embodiment of a septum used in the samplingarrangement of FIG. 2;

FIG. 6 is a top fractional view of another embodiment of a septum usedin the sampling arrangement of FIG. 2;

FIG. 7 is a cross sectional view of the septum shown in FIG. 5, takengenerally along line 7-7 of FIG. 5;

FIG. 8 is a fragmentary perspective view of a needle depicted in thesampling arrangement of FIG. 2;

FIG. 9 is an illustration of one embodiment of a regulating device thatcan be used in the sampling arrangement of the present invention;

FIG. 10 is a first, partially exploded, side view of one embodiment of alocking arrangement that can be used with the sampling arrangement inaccordance with the principles disclosed;

FIG. 11 is a second, partially exploded, side view of the lockingarrangement of FIG. 10;

FIG. 12 is a bottom plan view of one embodiment of a base of the lockingarrangement depicted in FIG. 10; and

FIG. 13 is a first side view of the locking arrangement of FIG. 10,shown with a locking device.

DETAILED DESCRIPTION

This invention provides an apparatus and method for the continuousaseptic sampling of fluid material from a fluid transportation system orfluid processing enclosure 5, schematically illustrated in FIG. 1. Afluid material 6 to be sampled is illustrated as flowing through a fluidline 20 by the fluid flow arrow designation “F”. A preferred samplingarrangement of the present invention is schematically illustrated at 10and is depicted as operatively connected, by the dashed line 8, tosample the fluid material 6 (as hereinafter described in more detail).

The principles described herein for the sampling arrangement 10 can beused in various industries and in various applications where asepticsampling of material is desired. Aseptic sampling involves transferringfluids to or from process systems that are sensitive to contaminationfrom the outside environment. For example, the pharmaceutical,bioengineering/biotechnology, brewing/distilling, food processing anddairy processing industries are in need of aseptic sampling technology.Such sampling technology can be applied broadly, the applicationsranging from process monitoring to laboratory and research applications.For example, the fluid processing enclosure or fluid transportationsystem 5 illustrated in FIG. 1 may comprise a dairy processing systemused in the dairy industry. An example of one type of fluid processingenclosure or fluid transportation system 5 that has been used in thedairy processing industry is described in U.S. Pat. No. 5,269,350 andherein incorporated by reference. In such a system, the fluid material 6therein may include raw milk or a processed milk product. The samplingarrangement 10 may be incorporated or retrofitted to the fluidtransportation system 5 to provide continuous aseptic sampling fordetecting microbial contamination or monitoring mastitis, coliform,food-borne illness bacteria, or spoilage bacteria in a dairy herd, forexample.

While preferred embodiments of this invention will be described withrespect to its sampling use and application in the dairy industry, itwill be understood that the invention is not to be construed as limitedto use in that industry or to the particular application described.

The Structural Components, Generally.

Referring to FIG. 2, the preferred sampling arrangement 10 depictedincludes: an elbow 12 having flanges 14 and a port 22; a least oneseptum or septum cartridge 40 (shown in phantom); a connecting conduit16; and a collection container 18. In general, the sampling arrangement10 comprises an arrangement that provides for a continuous draw of fluidfrom a flow F within a fluid line 20, and deposits the fluid sample inthe collection container 18 to provide the user with an accumulatedprocess sample. It is to be understood that the fluid line 20 maycomprise a variety of fluid transportation systems or fluid containmentenclosures, and is not limited to pipe constructions. The collectioncontainer 18 may include a pouch, bag, reservoir, or other closedcontainer of a typical construction and size, such as those used in themedical industry. In the illustrated embodiment, a medical type bagcomprising a 2-liter collection pouch or bag is used. A variety of sizesand constructions of containers is contemplated.

As illustrated, the pipe segment or elbow 12 of the sampling arrangement10 is in direct fluid communication with the fluid line 20 of the fluidtransportation system. In accordance with the principles of the presentinvention, it is desirable to perform sampling from an area or region ofnon-laminar flow within the line 20. The elbow 12 provides a turbulentor non-laminar flow region within its interior flow cavity by itsnon-linear configuration. It is to be understood that there are othermeans of creating a non-laminar flow region within the fluid flow line,such as having a protrusion or device extending into the flowing fluidwithin a substantially straight portion of the fluid line. Therein fluidturbulence or non-laminar flow is formed downstream of the extendingdevice or protrusion. Creation of a non-laminar sampling regioneliminates the problem of reversed fluid flow from the sample to themain fluid line, which commonly occurs in devices and methods of theprior art.

Referring now to FIGS. 3 and 4, the connection flanges 14 of the elbow12 extend circumferentially at each end of the elbow 12. The flanges 14may include grooves (shown in phantom) sized to receive sealing gaskets(not shown) to seal the connections between pipe segments when installedin common fluid transportation line systems. In accord with theprinciples of the present invention, the sampling arrangement isgenerally adapted to be retrofitted within existing fluid lines ofvarious fluid flow systems 5 (FIG. 1). Certainly the samplingarrangement 10 can be incorporated as original equipment into newinstallations of fluid transportation lines as well. Other means ofconnection or retrofit adaptation, including welding, are contemplatedas a means of installation. The sampling arrangement is generallydesigned with standard plumbing components to facilitate retrofitmodifications. It is to be understood that non-standard elements, suchas non-standard pipe diameter, fittings, or material, are within thescope of the principles disclosed.

Preferably the elbow 12 is made of industry standard stainless steel,such as 304 or 316L stainless steel. Other materials applicable for usein the industry into which the sampling arrangement is implemented arecontemplated. The elbow depicted in FIG. 3 incorporates a standard90-degree elbow. The angular configuration of the elbow will typicallybe a standard dimension within the range of 35 degrees to 180 degrees,typically 90 degrees. The preferred diameter of the elbow pipe is atleast 1 inch, typically from about 1.5 to 3.5 inches in diameter.

The elbow 12 according to the present invention includes at least oneaperture or port 22. The elbow 12 may be located in any configuration inthe fluid transportation system where the port 22 is operably in fluidcommunication with the fluid material 6 within the system. Thus, theinterior angle of the elbow 12 may be oriented, for example, upward,downward or sideways in a fluid line arrangement. It is alsocontemplated that to ensure that the port is operably in fluidcommunication with the fluid material 6, the port 22 may be configuredin alternative locations on the elbow 12. In the illustrated embodiment,the port 22 is located on the outer radius of the elbow 12. Alternativeembodiments may include, for example, an elbow having a port located onthe interior radius of the elbow. Preferably, the port 22 is disposed ator within a non-laminar flow region of the elbow 12.

As depicted in FIG. 3, the port 22 may include a transversely extendingpipe portion or conduit 26. The conduit 26 is sized to receive a septumcartridge 40. The conduit 26 may include an externally threaded region28 for purposes of securing the septum cartridge 40. In one embodiment,the thread comprises a standard 1.5″-8 ACME thread corresponding to amating internally threaded nut 30. The threaded nut 30 may include aninternal annular shoulder 32 (shown in phantom). The annular shoulder 32acts as a bearing surface that engages a first surface 46 of the septumcartridge 40 (shown also in FIG. 7) to secure the septum cartridge insealing manner when assembled within the port 22. Other types offasteners commonly used as securing or retaining means within thiscontext are contemplated and may include, for example, a hex nut, aknurled lock nut, or a keyed nut.

Referring generally to FIG. 2, the septum cartridge 40 is in fluidcommunication with the interior cavity of the fluid line 20 by means ofthe aperture or port 22 in the elbow 12. As shown in FIGS. 5-7, theseptum cartridge 40 generally comprises a cap 45, a central core memberor boot 49, and a plurality of guide holes 48 formed through the cap.For purposes of clarifying features, the septum cartridge 40 can beconsidered to have a top 41 and a bottom 42.

The cross-section of the boot 49 is seen to increase progressively fromthe bottom 42 toward the top 41 of the septum cartridge 40. The boot 49is sized such that when the boot is placed within the port 22 of theelbow there is compressive contact between the interior surfacesdefining the port 22 and the boot 49. The boot thereby functions as asealing member. The boot 49 illustrated is generally conical, but couldadopt a variety of shapes as will be obvious from the followingdiscussion of the functioning of the septum cartridge in combinationwith other components of the invention.

The boot 49 may be made of material that is generally considered to beof a rubber compound. While compounding of an acceptable rubbercomposition is believed to be within the skill of the rubber moldingart, it is found that rubber compounds based on ethylene propylene dienemonomer terpolymer (EPDM) are particularly advantageous, having suitablesealing characteristics. EPDM is a known elastomer, and recognized bythose skilled in the polymer arts. Other elastomers are contemplated,such as those derived from, or modified with, butene isoprene, ethylene,and the like. In an alternative embodiment, the boot may comprise asilicone compound. Silicone also provides suitable sealingcharacteristics. Materials such as Viton or other FDA approvedelastomers are also contemplated for use in manufacture of the boot.

Preferably, the cap 45 includes an annular radially extending portion 34defining the first upwardly oriented surface 46 and an opposing secondlower surface 47. The outer diameter of the annular portion 34 ispreferably only slightly less than the inner diameter of the internalshoulder 32 on the threaded nut 30 for purposes of engaging andretaining the septum cartridge 40 within the port 22 of the elbow in thesampling arrangement 10.

The cap 45 is made of a material that is normally not penetrable byconventional hypodermic needles. A typical material for fabrication ofthe cap may include one of the engineering plastics, such as nylon,polypropylene, or high-density polyethylene. The penetrability of theseptum cartridge 40 is thus provided by one or more of the integrallyformed guide holes 48, which begin from a top surface 43 of the cap 45and extend downwardly through the cap 45.

The guide holes 48 are integral with the cap 45 and located tocorrespond to the boot 49. The guide holes 48 extend downwardly throughthe cap structure 45 and are oriented and positioned so that a samplingneedle 50 (shown in FIG. 8) may pass through the guide hole 48 and intothe boot 49. The guide holes 48 are generally sized to be only slightlylarger than the needle, such that the needle slidably fits snugly withinthe guide hole, preferably without substantial friction, but with aclose enough fit to ensure that the guide hole provides direction to theneedle as it is inserted through the boot. In one embodiment (FIG. 5),the septum cartridge 40 a includes seven guide holes. In anotherembodiment (FIG. 6), the septum cartridge 40 b includes twelve guideholes. Typically the septum cartridge includes at least one guide hole,generally 1 to 15 guide holes.

A cover film 60 covers the top surface 43 of the cap 45, including theguide holes 48 formed in the top surface 43 of the cap 45. The coverfilm 60 easily identifies used holes to reduce the risk of contaminationfrom reinserting a needle into a previously used guide hole. The coverfilm 60 may be made from any readily pierceable film material. A typicalfilm material is a vinyl tape having an adhesive coating to securablyattach the cover film 60 to the top surface of the cap 45.

Referring to FIGS. 2 and 8, the penetrating body or needle 50 is influid communication with the connecting conduit 16, and the connectingconduit 16 is in fluid communication with the collection container 18.In the preferred embodiment, the needle comprises a beveled end 51having an aperture 52 that defines a hollow portion runninglongitudinally through the needle 50. It is to be understood that otherpenetrating bodies, such as lumens, hollow members, or inserting devicesmay be used in accordance with the principles disclosed.

In use, the needle 50 penetrates the cover 60, passes through a selectedguide hole 48, and penetrates through the boot 49. As the needlepenetrates the boot, the needle displaces the elastomeric/rubbermaterial of the boot which forms a fluid impenetrable seal about theneedle. The beveled end 51 of the needle 50 progresses through the boot49 and emerges from the boot at the bottom 42 of the septum cartridge40. The needle therein enters into the flow of fluid F.

The needle 50 is sized and adapted for use with the septum cartridge 40.Typically the needle comprises a 12 gauge to 22 gauge needle, preferablya 16 gauge needle. The needle generally has a length of from about 1.0inches to 4.5 inches. Preferably the needle is at least 1.5 inches inlength if the port 22 is bottom placement oriented and at least 2.0inches if the port 22 is top placement oriented. What is meant by topand bottom placement oriented is how the sampling port is oriented withrespect to ground. Thus, if the elbow is top placement oriented, alonger needle 50 is needed to ensure the needle aperture 52 is submergedwithin the fluid material when operatively inserted through the septum40.

Still referring to FIG. 2, the connecting conduit 16 also includessealing ends 62 at locations where the fluid flow transitions from theneedle 50 to the connecting conduit 16 and from the connecting conduit16 to the collection container 18. A typical, usable connecting conduitis the type used by the medical industry in fluid administration sets.Conduit in accordance with the principles disclosed includes, forexample, tubing, flexible piping or flexible lumen constructions thatprovide closed, aseptic fluid communication between ends.

Preferably the connecting conduit 16 is of sufficient length to reachfrom the elbow 12 to an area where the collection container 18 isplaced. The length may thus vary and typically falls within the range of5 inches to 65 inches, and preferably is about 38 inches in length. Inone embodiment, the connecting conduit comprises a 0.121 inch insidediameter and a 0.166 outside diameter. It is to be understood thattypical fluid administration sets having a needle, connecting conduit,and a collection pouch are contemplated for use in this samplingarrangement.

In use, the needle 50 is inserted through the septum 40 into anon-laminar fluid flow region of the elbow 12. Sampling at a non-laminarfluid flow region addresses the problem of reversed fluid flow oftencreated by a venturi effect of prior sampling systems. The venturieffect is created where the velocity of the laminar fluid flow flowingpast an orifice or tube opening (such as in a needle) causes acorresponding decrease in fluid pressure, which creates a siphoning orsuction. Thus, instead of drawing sampled fluid from the fluid line intoa collection container, sampled fluid is actually drawn from thecollection container back into the fluid line. The sampling arrangement10 of the present invention reduces or eliminates this problem.

Some Selected Alternate Embodiments

Alternative embodiments incorporating the principles of the presentinvention will be apparent from the description below and in the contextof the illustrations in FIGS. 2 and 9.

In one alternative embodiment, the sampling arrangement 10 includes aflow restricting device. The flow restricting device may comprise aclamp 64 as shown in FIG. 2. The clamp 64 compressively engages theouter surface of the connecting conduit 16 and is adjustable such thatflow through the tube may be restricted to a desired flow rate. Thereby,the continuous sampling rate may be increased or decreased duringsampling as needed.

Another embodiment of the sampling arrangement includes an alternativemeans of regulating flow. FIG. 9 depicts a fragmented portion of asampling arrangement including a metering or peristaltic pump 68. Theperistaltic pump 68 cooperatively engages connecting conduit 16 and isadjusted as is known in the art to provide a desired regulated flowrate.

The clamp 64 and the peristaltic pump 68 are products of commonmanufacture. The clamp may comprise any clamping device suitable toprovide restriction in the connecting conduit 16. The peristaltic pumpmay comprise, for example, a variable flow pump having a medium flowrate of 4.0 to 85.0 milliliters per minute. Specifically, a Medium Flowvariable flow pump, Model Number 54856-075, manufactured by MASTERFLEXis one variable flow pump that may be used.

Yet another embodiment of the present invention provides for cooling ofthe extracted sample held by the collection container. If it isdesirable to keep the extracted sample cool during collection, thecollection container 18 may be placed in an insulated cooler 70surrounded by ice or cold packs as shown in FIG. 1, for example. Commoncoolers can be modified to include a hole 72 in the top or lid throughwhich the connecting conduit 16 can be routed.

FIGS. 10-13 illustrates still another embodiment of the presentinvention including a tamper-resistant locking arrangement 80. Aspreviously described, the disclosed sampling arrangement 10 is coupledto the fluid processing enclosure or fluid handling/transport system 5.In this particular application, the fluid transport system 5 includes,for example, a tank 82. The tank may be any type of fluid-containingtank, such as the fluid processing enclosures 5 previously described,storage tanks, and even over-the-road transportation tanks, such as atanker truck, for example. The locking arrangement 80 is useful in anyapplication where product tampering or product removal may be ofconcern. The locking arrangement 80 is also useful in locations orprocessing areas that are less frequently monitored.

As shown in FIGS. 10-13, the locking arrangement 80 generally includes abase 102, a cover 84 and a locking device 86 (FIG. 13). The lockingarrangement 80 is configured to enclose the threaded nut 30 and septumcartridge 40 (FIGS. 5-7) of the sampling arrangement 10 to preventunwanted access to the internal volume of the tank 82.

Referring now to FIGS. 11, a hole 104 is formed in the base 102 of thelocking arrangement 80. In use, the base 102 is positioned at a conduit126 of the tank 82. As previously described, the conduit 126 is sized toreceive the septum cartridge 40 (see FIG. 3). In the illustratedembodiment, the conduit 126 includes a shoulder 106 upon which the base104 sets. An externally threaded region (shown for example in FIG. 3) ofthe conduit 126 extends through the hole 104 of the base 102. Thethreaded nut 30 of the sampling arrangement 10 is threaded onto theexternally threaded region for purposes of both securing the septumcartridge 40 within the conduit 126 and capturing the base 102 betweenthe nut 30 and the shoulder 106 of the conduit 126.

The cover 84 of the locking arrangement 80 is then positioned over thethreaded nut 30. As shown in FIGS. 10 and 11, the cover 84 is sized tofit between opposing sides 108 and opposing brackets 92 of the base 102.The opposing sides 108 and the opposing brackets 92 of the base 102extend outward from a main portion 110 (FIG. 12) of the base 102. In theillustrated embodiment, the sides 108 are shorter than the brackets 92.In use, the sides 108 aid to position the cover 84 in relation to thebase 102 so that the cover 84 is retained between the opposing sides 108of the base 102. The opposing brackets 92 are configured to extendoutward from the main portion 110 of the base 102 beyond the cover 84when positioned assembled as shown in FIG. 13. Each of the brackets 92includes a hole 94 (FIG. 11) that receives a rod 98 (FIG. 13) of thelocking device 86.

Referring to FIG. 13, when the rod 98 of the locking device 86 ispositioned through the holes 94 of the brackets 92, the rod 98 extendsacross the top of the cover 84 so that the cover 84 cannot be removed.Because the cover 84 cannot be removed, the top 41 of the septumcartridge 40 cannot be accessed; similarly, the threaded nut 30 cannotbe accessed. In addition, the main portion 110 of the base 102 alsoprevents access to the threaded nut 30. As can be understood a lock 100,such as a combination lock or key lock, is coupled to the rod 98 tosecure the locking device 86 and prevent unwanted access to the septumcartridge 40, the threaded nut 30, and the fluid contained within thetank 82. To access the septum cartridge, the locking device 86 isunlocked, and the cover 84 is simply removed.

Although the locking arrangement 80 has been described with respect to atank application, it is contemplated that the locking arrangement 80 canfurther be used in pipe system applications, such as the applicationshown in FIG. 2, or other fluid transport systems and processingenclosures.

The alternative embodiments herein described may be used in combinationwith each other or used independent of one another.

The Method of Continuous Sampling, Generally.

In operation, the elbow 12 is installed at a convenient samplinglocation along a fluid line 20. The elbow is preferably oriented suchthat the port 22 is in direct fluid contact with the materialtransferred within the fluid line, to reduce the potential of air drawnduring sampling.

The boot 49 of the septum cartridge 40 is placed into the sampling port22 until the second surface 47 of the cap 45 rests against the outeredge of the sampling port 22. The securing nut 30 is installed onto theconduit of the port 22 to sealingly, operatively secure the septumwithin the port.

For aseptic sampling, the sampling arrangement, including the port, nut,septum cartridge, etc, are sanitized with a common alcohol prep or othersanitizer. In particular, aseptic sampling is optimized when the coverfilm 60 is cleansed with a disinfectant, and a sterilized needle 50 isinserted through the disinfected cover film, through an unused guidehole, and through the septum boot.

The needle is preferably directed or slanted toward the center of theseptum boot at insertion. This provides greater assurance that theneedle penetrates through the entirety of the boot. In effect, the bootessentially squeegees or cleanses the needle of any contaminants missedduring initial aseptic disinfectant processes. Directing the needletoward the center of the boot also reduces the possibility of contactingthe wall of the extended portion of the elbow.

The needle may be oriented such that the beveled end 51 faces toward theflow of the fluid material to aid in fluid sampling. A pressuredifferential is applied between the collection container and the fluidline to effect the fluid sampling or material transfer. The pressuredifferential may be applied in a number of ways. One way is byintroducing pressure into the fluid line. Another is by reducingpressure in the connecting conduit or collection container. Any means ofgenerating an adequate pressure differential between the fluid line andthe collection container is effective to cause the flow of materialthrough the needle. Other methods of applying the pressure differentialand thus effecting the transfer of a sample will be obvious to thoseskilled in the art.

Material from a tank, for example, thus flows from the fluid line 20,through the needle 50, and into the collection container 18 by way ofthe connecting conduit 16. In one alternative application, thecollection container may be placed into a cooling container 70 of ice orice water, for example, to reduce or eliminate bacterial growth duringthe sampling process.

The flow from the fluid line 20 to the collection container 18 may beadjusted to a particular flow or sampling rate by means of the clamprestriction. The flow may likewise be metered wherein the peristalticpump is assembled to the connecting conduit to regulate the flow.

When the desired sample has been collected, the collection container isremoved from the connecting conduit 16 and sealed. The needle 50 isremoved from the septum cartridge 40. As the needle end is withdrawn,the material of the boot 49 withdraws into the position held prior toneedle penetration. The boot 49 of the septum 40 thus closes and sealsthe passageway of the now removed needle.

After performing a number of sampling procedures, so that all guideholes have been used, the septum cartridge 40 is removed and discarded.The punctured cover film 60 provides a ready indictor of those guideholes that have been used. A new septum cartridge easily replaces theused septum cartridge for future samplings.

Some Selected Alternate Methods of Use

Once a sample has been collected, the collection container 18 of thepresent invention may be used to determine any number of product qualitydefects. One use for determining product quality defects applies to thedairy industry; in particular, to detecting quality defects in dairyfluid products, such as milk, for example.

One such defect is post-pasteurization contamination (PPC). There aremany sources of post-pasteurization contamination including inadequatecleaning and sanitizing, contaminated water, engineering defects such ascracked tanks or other equipment components, condensation in compressedair lines, and other sources. Undoubtedly contamination from thesesources can result in poor keeping quality, consumer complaints, andreduced profits.

One of the primary causes of dairy product quality defects ispost-pasteurization contamination (PPC) with gram-negative psychrotrohicbacteria found in pasteurized milk. In recent years, research has shownthat the level of post-pasteurization contamination of gram-negativebacteria in pasteurized milk can be extremely low, but still affectdairy product quality. This research showed that contamination rates aslow as one bacterium per liter can cause spoilage and other productdefects in a short time if the growth rate of that bacterium isextremely fast. Other research has shown that the growth rate isdependent on storage temperature and oxygen concentrations of the milk.For example, it is possible for gram-negative bacteria to cause qualitydefects at 7° C. (45° F.) in a little as ten days under ideal growthconditions of saturated oxygen in milk.

The disclosed sampling arrangement 10 can be used to effectively monitordairy processes for the potential of contamination of the gram-negativepsychrotrophic bacteria. In particular, to monitor for possiblegram-negative bacteria contamination, the arrangement 10 is used toobtain an aseptic fluid sample within the collection container 18 at thedischarge of the HTST (High Temperature Short Time) pasteurizingprocessor. Because of the aseptic design of the sampling arrangement 10,contamination of both the fluid sample and the primary fluid flow duringsampling is prevented to preclude the sampling arrangement as a sourceof bacterial contamination. Typically, the size of the fluid sample isbetween about 50-500 ml in volume, however, the collection container 18can aseptically accommodate larger samples of up to about 5 liters.

In one embodiment, the collection container 18 preferably has an oxygenpermeability that simulates the level of oxygen to which the fluidproduct is exposed. For instance, the oxygen permeability preferablysimulates the oxygen saturation associated with pre-packing operationsand the product packaging within which the fluid will be stored. Bythis, the collection container 18 allows gram-negative bacteria to growin the same fashion as the bacteria would in product storage containers.In particular, the oxygen permeability of the collection container 18promotes the same growth rate of contaminate as there would be in aproduct that has been fully oxygen saturated through pumping, agitatingand filling procedures. The arrangement 10 thereby simulates the storageconditions for purposes of monitoring for gram-negative bacteria withoutthe addition of air or oxygen to a collected sample.

Once the desired fluid sample size is collected, the sample is permittedto incubate for a time period sufficient to allow for low-levelcontaminants to reach a level that can be counted by conventionallaboratory procedures. Typically, the incubation period corresponds tothe shelf life of the fluid product. In one method, for example, thefluid sample is incubated for a number of days at 45° F. During theincubation period, oxygen permeates the collection bag to oxygenate thefluid product. A Standard Plate Count is conducted during the incubationperiod to determine the level of gram-negative bacteria present withinthe sample. The Standard Plate Count can be repeated any number of timesduring the incubation period. Methods other than the Standard Platecount for detecting psychrotrophic bacteria (spoilage bacteria) can beused.

To illustrate the oxygen permeability of the collection bag 18, a studyof gram-negative psychrotrohic bacteria was conducted at the Universityof Minnesota's Biological Technology Institute. In this study, a fluidsample of sterilized milk was inoculated with pseudomonas bacteria at apopulation of about 60 organisms per liter. The inoculated milk wasfilled in three collection bags and three 60 cc syringes, and thenincubated in the refrigerator at 7° C. (45° F.). The three syringescontaining inoculated milk served as non-permeable container controls.Bags and syringes containing un-inoculated milk also served as controls(see Table 1 below). In the inoculated collection bags, the presence ofthe bacteria was clearly evident with six days. In contrast, theinoculated syringes required 21 days to positively confirm the presenceof bacteria. By using the disclosed sampling arrangement 10, the timeneeded to obtain contamination results is significantly shortened due tothe oxygen permeability feature of the collection bag 18. Reducing thetime needed to detect contamination saves in production costs andreduces product waste associated with continued production of acontaminated product. TABLE 1 Daily cell counts of bacteria (cfu/ml) Day0 3 6 7 8 9 10 13 15 21 Control bag 1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Controlbag 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 Bag 1 <1 1 15 80 169 334 750 2.2 × 10⁶6.510⁷ Bag 2 <1 1 15 70 110 200 350 1.0 × 10⁶ 10.5 × 10⁷ Bag 3 <1 2.5 1370 29 100 600 1.7 × 10⁶  6.0 × 10⁷ Control Syr 1 <1 <1 <1 <1 <1 <1 <1 <1<1 <1 Control Syr 2 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 Syr 1 <1 <1 <1 <1 <1 34 3 <1 21.5 Syr 2 <1 <1 <1 <1 <1 2 <1 <1 <1 3.5 Syr 3 <1 1 <1 1 <1 5 2 1<1 193

Another defect affecting the quality of dairy fluid products isspore-forming bacteria found in pre-pasteurized or raw milk. Raw milkquality can greatly influence the keeping quality of market milk. One ofthe primary causes of spore-forming bacteria is gram-positivepsychrotrohic bacteria. Spore-forming bacteria is generally caused bycontamination introduced in pre-pasteurization milk processes.Determining the level of spore-forming bacteria in a fluid productsample provides valuable information for evaluating the associatedproduction, cleaning processes and shelf life.

Research has also shown that the level of spore-forming contamination ofgram-positive bacteria in raw milk can be low, but still affect dairyproduct quality. For instance, spore-forming bacteria has been found tosurvive heat treatments of up to 176° F. at 10 minute intervals. Infact, the heat treatment in some cases has even activated sporegermination and outgrowth in milk. The disclosed sampling arrangement 10can be used to effectively monitor dairy processes for the potential ofcontamination of the gram-positive psychrotrophic bacteria.

In particular, to monitor for possible gram-positive bacteriacontamination, the arrangement 10 is used to obtain an aseptic fluidsample within the collection container 18. Because of the aseptic designof the sampling arrangement 10, contamination of both the fluid sampleand the primary fluid flow during sampling is prevented to preclude thesampling arrangement as a source of spore-forming bacteriacontamination.

Spore-forming bacteria is inherent in raw milk, however, an excessiveamount of spore-forming bacteria, or the presence of spore-formingbacteria that has an accelerated growth rate is undesirable and willmost likely result in unacceptable milk quality at refrigerationtemperature. The collection container 18 of the present samplingarrangement 10 has an oxygen permeability that provides a level ofoxygen saturation that accelerates the growth rate of spore-formingbacteria. By this, the collection container 18 allows gram-positivebacteria to grow in an accelerated fashion to determine the amount ofgram-positive bacteria present.

Once the desired fluid sample size is collected (e.g., up to 5 liters),the sample is permitted to incubate for a time period sufficient toallow for the spore-forming contaminants to grow. For example, in onemethod, the fluid sample is incubated for a period of time approximateto the standard product shelf life, e.g., 18-24 days, at 45° F. Duringthis period, oxygen permeates the collection bag to oxygenate the fluidproduct. A conventional laboratory procedure, such as a Standard PlateCount, is then conducted after the period of time to determine the levelof gram-positive bacteria present within the sample. A level ofgram-positive bacteria greater than 10,000,00 counts/ml, for example,would indicate that the spore-forming bacteria present has the potentialfor causing product quality defects. This information can then be usedto re-evaluate production and cleaning process to reduce the likelihoodof future quality problems.

To illustrate the oxygen permeability of the collection bag 18, a studyof gram-positive psychrotrohic bacteria was conducted at the Universityof Minnesota's Biological Technology Institute. In this study, a fluidsample of raw milk was collected in the disclosed bag. The bag wasincubated for 18-24 days at a temperature of about 7° C. (45° F.). Astandard plate count was then conducted. Using gram-stain procedures,the samples having bacteria counts of greater than 10,000,000/ml wereidentified (see Table 2 below). Identifying the samples having highbacteria counts reduces product waste associated with continuedproduction of a contaminated product. TABLE 2 Cell counts of bacteria(cfu/ml) Week 1 Week 2 Week 3 Week 4 Volume CFU/ml CFU/ml CFU/ml CFU/mlSample Dairy Bag L Gram− Gram+ Gram− Gram+ Gram− Gram+ Gram− Gram+ Date:Mar. 23, 2004 Mar. 30, 2004 Apr. 7, 2004 Apr. 13, 2004 Day: 7 14 22 28Mar. 16, 2004 Plant B A 1.3 <10 <10 <10 <10 <10 <10 <10 <10 Tuesday B1.5 <10 <10 <10 <10 <10 <10 <10 <10 Date: Mar. 24, 2004 Mar. 31, 2004Apr. 7, 2004 Apr. 15, 2004 Day: 7 14 21 29 Mar. 17, 2004 Plant A A 1.2<10 <10 <10 <10 <10 7.56 × 10⁴ <10 1.0 × 10⁶ Wednesday B 1.2 <10 <10 <10<10 <10 2.33 × 10⁴ <10 1.93 × 10⁶  Date: Mar. 31, 2004 Apr. 7, 2004 Apr.15, 2004 Apr. 21, 2004 Day: 7 14 22 28 Mar. 24, 2004 Plant A A 11.2 <10<10 <10 3.0 × 10² <10 1.41 × 10⁶ <10 1.05 × 10⁷  Wednesday B 1.2 <10 <10<10 0.4 × 10² <10 0.95 × 10⁶ <10 3.1 × 10⁷ Date: Apr. 7, 2004 Apr. 14,2004 Apr. 21, 2004 Apr. 28, 2004 Day: 7 14 21 28 Mar. 31, 2004 Plant A A1.2 <10 <10 <10 <10 <10 <10 <10 <10 Wednesday B 1.2 <10 <10 <10 <10 <10<10 <10 <10 Date: Apr. 9, 2004 Apr. 16, 2004 Apr. 23, 2004 Apr. 30, 2004Day: 7 14 21 28 Apr. 2, 2004 Plant B A 1.0 <10 <10 <10 7.7 × 10² <10 6.7 × 10⁵ <10 2.5 × 10⁶ Friday B 1.1 <10 <10 <10 5.8 × 10² <10 4.96 ×10⁵ <10 6.5 × 10⁶ Date: Apr. 22, 2004 Apr. 29, 2004 May 6, 2004 May 12,2004 Day: 7 14 21 27 Apr. 15, 2004 Plant B A 1.1 <10 <10 <10 <10 <10 <10<10   6 × 10  Thursday B 1.2 <10 <10 <10 <10 <10 <10 <10 <10

The above specification, examples and data provide a completedescription of the manufacture and use of the invention. Manyembodiments of the invention can be made according to the disclosedprinciples.

1. A fluid system, comprising: a) a transportable fluid vessel having anaperture that provides access to an interior volume; b) an asepticsampling arrangement configured to provide aseptic sampling of a fluidcontained within the interior volume of the transportable fluid vessel,the aseptic sampling arrangement including a septum and a securingelement, the septum being secured within the aperture of the fluidvessel by the securing element, the septum including a penetrable bodyconstructed for penetration of a needle therethrough; and c) a lockingarrangement that provides selective access to the aseptic samplingarrangement.
 2. The fluid system of claim 1, wherein the transportablefluid vessel is a tanker truck.
 3. The sampling arrangement of claim 1,wherein the locking arrangement includes: a) a base; b) a cover sized tofit over the septum; and c) a locking device arranged to secure thecover in relation to the base.
 4. The sampling arrangement of claim 3,wherein the base of the locking arrangement is configured to preventaccess to the securing element of the aseptic sampling arrangement. 5.The sampling arrangement of claim 4, wherein the septum and the securingelement are enclosed within the base and the cover to prevent unwantedaccess to the internal volume of the transportable fluid vessel.
 6. Thesampling arrangement of claim 5, wherein the base includes sidesextending outward from a main portion, and wherein the cover is sized tofit between the sides of the base to enclose the septum and the securingelement.
 7. The sampling arrangement of claim 1, wherein the septumcomprises: a) a penetrable body; b) a cap piece; and c) a penetrablelayer at least partially covering a portion of the cap piece.
 8. Thesampling arrangement of claim 7, wherein the securing element is athreaded nut.
 9. A aseptic sampling arrangement for a fluid enclosure,comprising: a) a septum configured for receipt within an aperture of afluid enclosure, the septum including a boot, the boot being constructedto seal the aperture of the fluid enclosure and provide for penetrationof a needle therethrough; and b) a locking arrangement configured toprovide selective access to the septum.
 10. The sampling arrangement ofclaim 9, further including a securing element configured to secure theseptum within the aperture of the fluid enclosure.
 11. The samplingarrangement of claim 10, wherein the locking arrangement providesselective access to the septum and the securing element.
 12. Thesampling arrangement of claim 11, wherein the securing element is athreaded nut.
 13. The sampling arrangement of claim 9, wherein thelocking arrangement includes: a) a base; b) a cover sized to fit overthe septum; and c) a locking device arranged to secure the cover inrelation to the base.
 14. The sampling arrangement of claim 13, furtherincluding a securing element configured to secure the septum within theaperture of the fluid enclosure, wherein the base of the lockingarrangement prevents access to the securing element.
 15. The samplingarrangement of claim 14, wherein the septum and the securing element areenclosed within the base and the cover to prevent unwanted access to theinternal volume of the fluid enclosure.
 16. The sampling arrangement ofclaim 15, wherein the base includes sides extending outward from a mainportion, and wherein the cover is sized to fit between the sides of thebase to enclose the septum and the securing element.
 17. The samplingarrangement of claim 9, wherein the septum further includes a cap pieceand a penetrable layer at least partially covering a portion of the cappiece.
 18. The sampling arrangement of claim 9, wherein the septum isconfigured for receipt within an aperture of a transportable fluidvessel.
 19. The sampling arrangement of claim 18, wherein thetransportable fluid vessel is a tanker truck.
 20. A method of providingselective aseptic access to a transportable fluid enclosure, the methodcomprising the steps of: a) positioning a septum of an aseptic samplingarrangement within an aperture of the transportable fluid enclosure; b)securing the septum within the aperture of the fluid enclosure with asecuring element; c) enclosing the septum and the securing elementwithin a locking arrangement to prevent unwanted access to the septumand the securing element; d) locking the locking arrangement to permitonly selective access to the septum and the securing element of theaseptic sampling arrangement.